Events

Alerta De Seguridad para Product name: ANESTHETIC VAPORIZERS /// Registration number: 10407370119 /// Affected version (s): D-Vapor / / / Product hazard class: III.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por DRAGER INDUSTRIA E COMERCIO LTDA.; DragerWerk AG & Co. KGaA..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1921
  • Fecha
    2016-06-28
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    If in doubt, contact the record holder of the company.
  • Causa
    The company drager do brasil sent anvisa the field action nº. pr60706_tsb 210 reporting that in monitoring its products it became aware of isolated cases of undesired release of agent (anesthetic) evaporation at the end of the replenishment procedure. the conclusion of the company's risk assessment reveals that "the release may lead to aerosol spraying on the operator's face and eyes. anvisa makes it clear that more information has been requested from the company and is waiting to update the information contained in this field action.
  • Acción
    Field Classification: Letter to the Client /// Field Action Code: PR60706_TSB 210 /// Recommendations to Users and Patients: Do not fill a vaporizer unless the user has received training and read the instructions for use; if during filling it is necessary to use more force than usual or if the bottle does not move down to the final position after filling automatically, support the bottle back after filling carefully pulling back against the final position; do not remove the vial quickly from the vaporizer after the completion of the filling and wait for 2 to 3 seconds to allow complete drainage of the dead space; use PPE as safety glasses during the filling process.

Device

Product name: ANESTHETIC VAPORIZERS /// Registration number: 10407370119 /// Affected version (s)...

Manufacturer

DRAGER INDUSTRIA E COMERCIO LTDA.; DragerWerk AG & Co. KGaA.